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Diagnostic Device

AI-Enabled Handheld Echocardiography for Heart Failure (MAPLE-CHF Trial)

N/A

Waitlist Available

Research Sponsored by Montreal Heart Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female ≥40 years of age

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

MAPLE-CHF Trial Summary

This trial will use electronic medical records and a blood test to identify people at risk of heart failure, then use a portable ultrasound and AI to diagnose them.

Who is the study for?

This trial is for men and women over 40 who have at least two risk factors for heart failure, such as coronary artery disease, diabetes, atrial fibrillation, stroke history, peripheral arterial disease, chronic kidney disease or long-term use of certain diuretics. It's not open to those with cognitive impairments that prevent informed consent or a previous diagnosis of heart failure.Check my eligibility

What is being tested?

The MAPLE-CHF trial tests an AI-enabled handheld echocardiogram (ECHO) tool from Us2.ai after screening patients using blood samples for specific heart hormones. This approach aims to diagnose high-risk individuals early by providing quick and reliable cardiac assessments.See study design

What are the potential side effects?

Since the intervention involves diagnostic procedures rather than medications or invasive treatments, side effects are minimal but may include discomfort during the ECHO procedure or anxiety related to testing.

MAPLE-CHF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 40 years old or older.

MAPLE-CHF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary endpoint

Secondary outcome measures

Secondary endpoints

MAPLE-CHF Trial Design

2Treatment groups

Experimental Treatment

Group I: CONTROL routine care armExperimental Treatment1 Intervention

Patients randomized to usual care will undergo standard clinical follow-up, with NT-proBNP and conventional echocardiography prescribed only as per usual practice.

Group II: ACTIVE investigational arm (NT-proBNP + AI-ECHO)Experimental Treatment1 Intervention

NT-proBNP will be performed in all individuals randomized to the ACTIVE arm at the same visit as informed consent; those with elevated NT-proBNP (≥125pg/ml) will undergo an Us2.ai (AI-enabled report) handheld echocardiogram within one month of NT-proBNP testing. A standard echocardiographic study will be performed if the AI-echo is non-diagnostic.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Montreal Heart InstituteLead Sponsor

120 Previous Clinical Trials

67,461 Total Patients Enrolled

24 Trials studying Heart Failure

9,321 Patients Enrolled for Heart Failure

Media Library

Us2.ai handheld echocardiogram (Diagnostic Device) Clinical Trial Eligibility Overview. Trial Name: NCT05860608 — N/A

Heart Failure Research Study Groups: ACTIVE investigational arm (NT-proBNP + AI-ECHO), CONTROL routine care arm

Heart Failure Clinical Trial 2023: Us2.ai handheld echocardiogram Highlights & Side Effects. Trial Name: NCT05860608 — N/A

Us2.ai handheld echocardiogram (Diagnostic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05860608 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an open enrollment period for this experiment?

"It appears that the trail, posted on September 1st 2023 and last edited May 8th 2023 is no longer in need of patients. Nevertheless, there are over 700 other medical studies recruiting participants at this moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Multidisciplinary Approach for High-risk Patients Leading to Early Diagnosis of Canadians With Heart Failure

Anique Ducharme 2023. "Multidisciplinary Approach for High-risk Patients Leading to Early Diagnosis of Canadians With Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05860608.